Grofibrat M

Leaflet accompanying the packaging: patient information

Grofibrat M, 267 mg, hard capsules

Fenofibrate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Grofibrat M and what is it used for
• 2. Important information before taking Grofibrat M
• 3. How to take Grofibrat M
• 4. Possible side effects
• 5. How to store Grofibrat M
• 6. Contents of the pack and other information

1. What is Grofibrat M and what is it used for

Grofibrat M belongs to a group of medicines known as fibrates. These medicines are used to lower the level of fats (lipids) in the blood. Examples of such fats include triglycerides. Grofibrat M is used in combination with a low-fat diet and other non-drug treatments, such as physical exercise and weight loss, which aim to lower the level of fats in the blood.

2. Important information before taking Grofibrat M

When not to take Grofibrat M

• if the patient is allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6)
• if the patient has had an allergic reaction to sunlight or UV radiation, or skin damage (with medicines such as other fibrates or the anti-inflammatory medicine ketoprofen) in the past
• if the patient has severe liver, kidney, or gallbladder disease
• if the patient has pancreatitis (a disease that causes abdominal pain), which is not caused by high levels of fats in the blood.

Do not take Grofibrat M if any of the above applies to you. In case of doubts, consult a doctor or pharmacist before taking Grofibrat M.

Warnings and precautions

Before starting to take Grofibrat M, discuss it with your doctor or pharmacist if:

• you have liver or kidney disease
• you have hepatitis: symptoms include yellowing of the skin and whites of the eyes (jaundice) and increased liver enzyme activity (confirmed by laboratory tests)
• you have hypothyroidism (reduced thyroid activity). If any of the above warnings apply to you (or in case of doubts), consult a doctor or pharmacist before starting to take Grofibrat M.

Muscle effects

Stop taking the medicine immediately and consult a doctor if you experience unexpected muscle cramps or pain, muscle tenderness or weakness while taking Grofibrat M.

• The medicine may cause muscle disease, which can be severe.
• These conditions are rare but include muscle inflammation and breakdown. This can cause kidney damage or even death. Your doctor may order a blood test to check the condition of your muscles before and after starting treatment.

The risk of muscle breakdown may be higher in some patients. Inform your doctor if:

• you are over 70 years old
• you have kidney disease
• you have thyroid disease
• you drink large amounts of alcohol
• you or a family member have had hereditary muscle diseases
• you are taking cholesterol-lowering medicines called statins, such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin
• you have had muscle diseases while taking statins or fibrates such as fenofibrate, bezafibrate, or gemfibrozil in the past.

If any of the above warnings apply to you (or in case of doubts), consult a doctor or pharmacist before starting to take Grofibrat M.

Grofibrat M and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take. In particular, inform your doctor or pharmacist if you are taking:

• blood-thinning medicines (e.g., warfarin)
• other medicines used to control the level of fats in the blood (such as statins or fibrates). Taking a statin at the same time as Grofibrat M may increase the risk of muscle damage.
• medicines used to treat diabetes (such as rosiglitazone, pioglitazone)
• cyclosporin (an immunosuppressive medicine). If any of the above warnings apply to you (or in case of doubts), consult a doctor or pharmacist before starting to take Grofibrat M.

Grofibrat M with food, drink, and alcohol

It is important to take the medicine with a meal, as it will work less well if taken on an empty stomach.

Pregnancy, breastfeeding, and fertility

• Do not take Grofibrat M and inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.
• Do not take Grofibrat M while breastfeeding. Consult a doctor or pharmacist before taking this medicine.

Driving and using machines

Grofibrat M has no effect on driving or using machines. Grofibrat M contains lactose and sodium. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Grofibrat M

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist. Your doctor will determine the appropriate dose of the medicine based on your condition, current therapy, and personal risk.

Taking the medicine

• Swallow the capsule whole with a glass of water.
• Do not open or chew the capsule.
• Take the capsule with a meal - absorption of the medicine on an empty stomach is worse.

How much to take

The recommended daily dose is 1 capsule of 200 mg once a day. Your doctor may increase the dose to 1 capsule of 267 mg once a day.

Patients with kidney problems

In patients with kidney problems, the doctor may reduce the dose. In case of such disorders, consult a doctor or pharmacist. In patients with severe kidney problems (creatinine clearance <20 ml min), the medicine is contraindicated.< p>

Patients over 65 years old

In patients over 65 years old without kidney problems, the recommended dose is the same as for adults.

Patients with liver problems

In patients with liver problems, Grofibrat M is not recommended due to the lack of clinical data for this group.

Use in children and adolescents

Grofibrat M is not recommended for use in children and adolescents under 18 years old.

Taking more than the recommended dose of Grofibrat M

In case of taking a higher dose than recommended, or accidental ingestion of the medicine by another person, consult a doctor or the emergency department of the nearest hospital immediately.

Missing a dose of Grofibrat M

• In case of missing a dose, take the next dose with the next meal.
• Then take the usual dose at the scheduled time.
• Do not take a double dose to make up for the missed dose.

In case of doubts, consult a doctor.

Stopping treatment with Grofibrat M

Do not stop treatment without consulting a doctor, unless the medicine causes bad feelings. Elevated cholesterol levels must be treated for a long time. Remember that, in addition to taking Grofibrat M, it is equally important to:

• follow a low-fat diet
• perform regular physical exercises. In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Grofibrat M can cause side effects, although not everybody gets them.

In case of any of the following serious side effects, stop taking Grofibrat M and consult a doctor immediately, as prompt treatment may be necessary:

Uncommon:may affect up to 1 in 100 people

• muscle cramps or pain, muscle tenderness or weakness - these may be symptoms of muscle inflammation or breakdown, which can cause kidney damage or even death
• abdominal pain - these may be symptoms of pancreatitis
• chest pain and shortness of breath - these may be symptoms of blood clots in the lungs (pulmonary embolism)
• pain, redness, and swelling of the legs - these may be symptoms of blood clots in the legs (deep vein thrombosis)

Rare:may affect up to 1 in 1,000 people

• allergic reaction, symptoms may include swelling of the face, lips, tongue, or throat, which may cause difficulty breathing
• yellowing of the skin and whites of the eyes (jaundice) or increased liver enzyme activity - these may be symptoms of hepatitis

Frequency not known:frequency cannot be estimated

• severe skin rash with redness, peeling, and swelling of the skin, resembling severe burns
• chronic lung disease

If you experience any of the above symptoms, stop taking Grofibrat M immediately and consult a doctor.

Other side effects:

If you experience any of the following side effects, consult a doctor or pharmacist:
Common:may affect up to 1 in 10 people

• diarrhea
• abdominal pain
• bloating with gas
• nausea
• vomiting
• increased liver enzyme activity in the blood - confirmed by laboratory tests
• increased homocysteine levels in the blood (high levels of this amino acid in the blood are associated with a higher risk of coronary heart disease, stroke, and peripheral vascular disease, although a causal relationship has not been established yet)

Uncommon:may affect up to 1 in 100 people

• headache
• gallstones
• decreased sex drive
• rash, itching, or hives
• increased creatinine levels in the blood - confirmed by laboratory tests

Rare:may affect up to 1 in 1,000 people

• hair loss
• increased urea levels in the blood - confirmed by laboratory tests
• increased sensitivity of the skin to sunlight, sunlamps, and sunbeds
• decreased hemoglobin levels (the protein that carries oxygen in the blood) and decreased white blood cell count - confirmed by laboratory tests

Frequency not known:frequency cannot be estimated

• muscle breakdown
• complications related to gallstones
• feeling tired

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Grofibrat M

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month. Do not store above 25°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Grofibrat M contains

The active substance is 267 mg of micronized fenofibrate. The other ingredients are: lactose monohydrate, maize starch, crospovidone (type B), magnesium stearate, sodium lauryl sulfate. The composition of the gelatin capsule shell is: body: titanium dioxide (E 171), gelatin; cap: titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E 172), gelatin.

• The capsule shell contains titanium dioxide (E 171), which may cause an allergic reaction.

What Grofibrat M looks like and contents of the pack

The medicine is available in the form of hard, elongated capsules, size 0, colored: cap - orange, body - white. Available packs: 30, 60, or 90 capsules, packaged in aluminum/PVC foil blisters, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
phone: +48 (22) 755 50 81
In order to obtain more detailed information, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22) 755 96 48
[email protected]

Date of last revision of the leaflet:

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